Quality Assurance Associate II, PHL
: Job Details :

DescriptionQuality Assurance Associate I, PHLMain Duties and Responsibilities1. Implement, communicate and maintain company's quality systems at the facility, incompliance with Marken's Global Quality Management System (QMS) requirements.2. Interact with clients on Quality Assurance (QA)/ GxP related matters under managementsupervision.3. Effectively interact with Marken Departments and stakeholders to maintain that all QAtasks are appropriately supported by QA.4. Support on internal audits including report preparation and assessment and tracking ofassociated corrective and preventive actions (CAPA).5. Support audits of external service providers as part of the vendor selection process. Follow up and tracking all commitments for actions or changes made by Marken from previousaudits, including report preparation.6. Support client audits and regulatory inspections, including the preparation of appropriatematerials required within those audits when applicable.7. Collate issues, CAPA, Risk Assessment, Change control and training metrics and identify quality improvement initiatives. Oversee activities that conclude on the appropriate close-out of all CAPA entries.8. Identify relevant GxP/ Quality related training needs and deliver or make they are deliverwhere required.9. Ensuring that the Marken Quality System and GxP Program are implemented andmaintained.10. Assisting in the evaluation of Marken-designated vendors and/or out-sourced activities. 11. Ensuring the accuracy and quality of records and documents.12. Participate actively in all the internal Quality and/ or designated meetings.13. Perform QA visual/ physical inspection of pharmaceutical products in accordance withinternal procedure and client specific requirements.14. Perform a review and release of incoming material receipts in accordance with relevantSOPs.15. Perform verification and approval of label printing process and additional labelling/repackaging activities.16. Perform the QA activities required Solo (warehouse movement, inventory status control)for the facility.Requirements:Related knowledge of Good Manufacturing Practice, Good Storage Practice and Good Distribution Practice guidelines.Detailed orientedOral and written communication skillsGood interpersonal skills, understanding of GDP and ISO CompliancePrevious experience in Quality Management Systems.Organized, methodical and efficient approach to work.Proficient use of Microsoft officeFluent in EnglishMinimum of 1 year of experience working in a Quality Assurance role within a GSP/GMP/GDP regulated position.Minimum High/ Secondary School diploma/ or equivalent with experience in relevant job related skills.